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The goal of this clinical trail is to investigate the efficacy and safety of PD-1 antibody Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).
This phase I study is being conducted to establish efficacy and safety of Tislelizumab plus TP regimen (taxane combined with platinum) as neoadjuvant therapy for patients diagnosed as local advanced cervical carcinoma (FIGO staging IB2-IIB).
All enrolled patients will receive same intervention. Treatment naïve patients who are diagnosed as local advanced cervical squamous cell carcinoma will receive Tislelizumab plus TP regimen before surgery for 3 cycles. After treatment, radiographic evaluation will be performed to assess clinical efficacy. Patients who have objective response will undergo radical surgery. Patients who are disease stable or progression will undergo radical chemoradiotherapy. The primary endpoint is major pathological response rate (MPR).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tislelizumab plus TP regimen as neoadjuvant therapy for local advanced cervical carcinoma | Experimental | Experimental: Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin The subjects enrolled in this trial will receive tislelizumab 200mg ivgtt d1, paclitaxel (175mg/m2 ivgtt d1) or docetaxel (75mg/m2 ivgtt d1), cisplatin (75mg/m2 ivgtt d1) or carboplatin (AUC=5 ivgtt d1). The regimen will be repeated every 3 weeks for 3 cycles. Chemotherapy regimen will be selected by investigators. Subjects will be enrolled serially. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tislelizumab, paclitaxel/docetaxel, cisplatin/carboplatin | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Major pathological response (MPR) rate | Major pathological response rate is defined as the percentage of participants having ≤10% viable tumor cells in the resected primary tumor and all resected lymph nodes following completion of neoadjuvant therapy. | Up to approximately 8 weeks following completion of neoadjuvant treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological Complete Response (pCR) Rate | rate is defined as the percentage of participants having an absence of residual invasive cancer in resected lung specimens and lymph nodes following completion of neoadjuvant therapy. | Up to approximately 8 weeks following completion of neoadjuvant treatment |
| Objective response rate (ORR) |
| Measure | Description | Time Frame |
|---|---|---|
| Biomarkers analysis | The association between biomarkers expression (eg. PD-L1 CPS) in primary tumor and efficacy. | Up to approximately 12 months |
Inclusion Criteria:
Exclusion Criteria:
9. Other unsuitable conditions determined by investigators.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yan Shi | Contact | 13810561979 | sy_rjh@aliyun.com |
| Name | Affiliation | Role |
|---|---|---|
| Yan Shi | Ruijin Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital, Shanghai JiaoTong University School of Medicine | Shanghai | China |
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| ID | Term |
|---|---|
| C000707970 | tislelizumab |
| D017239 | Paclitaxel |
| D000077143 | Docetaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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|
Objective Response Rate is defined as the percentage of patients with a documented complete response or partial response (CR + PR) based on RECIST v1.1. |
| Up to 30 days after last completion of neoadjuvant treatment |
| Relapse free survival (RFS) | Relapse free survival is defined as the time from surgery to first local, regional, or distant tumor recurrence or metastasis, or deaths. | Up to approximately 36 months |
| Disease free survival (DFS) | disease-free survival (DFS) is defined as surgery until documented disease recurrence or death from any cause in all patients (ITT population) who undergo surgery | Up to approximately 36 months |
| Adverse Events | All patients who have received at least one dose of treatment will be included in the safety analysis. Number of participants with treatment-related adverse events as assessed by CTCAE v5.0 | Up to approximately 12 months |
| Overall survival (OS) | Overall survival is defined as the time from signing ICF until death from any cause. | Up to approximately 60 months |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |